To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.
Study Details
Study Description
Brief Summary
The latest international research shows that supplementation of hydrogen molecules as an aid, adjuvant, can speed up the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different dose exposures for a clinical study in rheumatologic and metabolic patients. Patients will receive a different dosage of hydrogen capsules with their conventional treatment for a month. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
According to the current literature, there is a lack of specific drugs for chronic inflammatory symptoms which develop from many refractory diseases with complicated clinical features. Hydrogen supplement has been shown to have significant removal effects on free radicals and reduce chronic inflammation. With these benefits, molecular hydrogen may have the ability to speed up the recovering the disease.
The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in the different doses of hydrogen capsules for a clinical study in rheumatologic and metabolic patients.
Study design: 15 rheumatologic patients and 15 metabolic patients will be recruited from the Min-Sheng General Hospital for this study. Participants will be screened by doctors for their eligibility and undergo a series of tests (questionnaires and examinations). Consenting participants will then be allocated into 3 groups by different dosage (Low, n=5; Medium, n=5; High, n=5). Participants will receive 1 (Low), 3 (Medium) or 6 (High) capsules every day for one month. Participants will be examined their regular haematology, urine and health status before and after the intervention.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hydrogen capsules Participants will be allocated by doctors and receive either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month. |
Drug: Hydrogen
Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
|
Outcome Measures
Primary Outcome Measures
- Adverse effects/symptoms [up to 28 days]
Any adverse effects will be codified according the the NCI CTCAE v5.0
Secondary Outcome Measures
- Change in physiological parameter (Blood Routine) [Change from Baseline Blood Routine at Day 28]
Numerical change in Blood Routine
- Change in physiological parameter (Urine Routine) [Change from Baseline Urine Routine at Day 28]
Numerical change in Urine Routine
- Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions) [Change from Baseline BFI-T at Day 28]
Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome.
- Control status scale for diabetics (CSSD70) (First part: 11 questions) [Change from Baseline CSSD70 at Day 28]
Questionnaire for metabolic patients minimum values:0 maximum values:22 Higher scores mean a worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 20 to 70 with autoimmune or metabolic diseases
-
Able to compliant with the protocol
-
Able to return to the hospital regularly
Exclusion Criteria:
-
Pregnancy
-
Expected pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Min-Sheng Gereral hospital | Taoyuan | Taiwan |
Sponsors and Collaborators
- HoHo Biotech
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021007-A